Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 20 June 1988 to 5 August 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): XRD-498

- Physical state: white powder
- Analytical purity: 99.6%

- Lot/batch No.: AGR 240043

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories Inc., Kingston, New York

- Fasting period before study: fasted the night before treatment
- Housing: two or three per cage
- Diet (e.g. ad libitum): Purina certified rodent chow #5002, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: one week



Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: corn oil:acetone
Details on oral exposure:
5 rats per sex received 5000 mg of test material per kg body weight by single dose gavage. The test material was administered as a 50% suspension in corn oil:acetone (9:1). All animals were fasted the night before treatment. Feed was provided to all rats following administration of the test material.
Doses:
5000 mg of test material per kg body weight
No. of animals per sex per dose:
5 rats per sex received 5000 mg of test material per kg body weight by single dose gavage
Control animals:
not specified
Details on study design:
Five rats per sec recieved 5000 mg of test material per kg body weight by single-dose gavage. The test material was administered as a 50% suspension in corn oil:acetone. All animals were fasted the night before treatment. Feed was provided to all rats following administration of the test material. Careful clinical observations were made once each working day, and recorded. Each animal was weighed the day of treatment and on test days 2, 8, and 15.
Statistics:
Means and standard deviations of body weights were calculated, and statistical outliers were evaluated.

Results and discussion

Preliminary study:
no information
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality.
Clinical signs:
All rats were in apparent good health throughout the study.
Body weight:
All animals gained weight throughout the observation period.
Gross pathology:
No gross pathologic changes in any of the rats at necropsy
Other findings:
no information

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: US EPA pesticides
Conclusions:
Under conditions of this study, the acute oral LD50 of XRD-498 was greater than 5000 mg/kg. Based on these results, the acute oral toxicity of XRD-498 was categorized as extremely low.
Executive summary:

XRD-498 was evaluated for acute oral toxicity in Fischer 344 rats. Five rats per sex recieved 5000 mg/kg of XRD-498 by single dose gavage. Parameters examined during the two week observation period included body weights and in-life clinical observations. All animals were examined for gross pathologic observations. All animals survived the 5000 mg/kg limit test established by the guidelines and therefore no other dose level was tested. All animals were in apparent good health throughout the study termination. There were no gross pathologic changes in any of the rats at necropsy. Under the conditions of this study, the acute oral LD50 or XRD-498 was greater than 5000 mg/kg. Based on these results, the acute oral toxicity of XRD-498 was categorized as extremely low.